STN Number: 125259/0
Manufacturer: GlaxoSmithKline Biologicals
Product: Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
From: Helen S. Gemignani, Regulatory Project Manager, RRB2/DVRPA/OVRR/CBER
Through: Elizabeth M. Sutkowski, Ph.D., Branch Chief, RRB3/DVRPA/OVRR/CBER
Subject: Review of Container and Packaging Labeling
Container and packaging labels were submitted with the original BLA on March 29, 2007, and to BLA Amendments submitted on November 8, 2007 and September 29, 2009, and via email to CBER on September 21 and 28, 2009.
Container labels were submitted for 0.5 mL single dose vial and 0.5 mL single dose syringe presentations. Packaging labels were submitted for 1 x 0.5 mL single dose syringes, 5 x 0.5 ml single dose syringes, and 10 x 0.5 mL single dose vial presentations.
CBER review comments, on the labeling components submitted on September 21, 2009, were provided to GSK on September 25, 2009. Those comments are as follows:
General Container and Package Comments
- Ensure all container and package labels have the proper name point size and typeface at least as prominent as the point size and typeface used in designating the trade name (21 CFR 610.62 (b)).
- The logo placement on the cartons is highlighting and separating the trade name from the proper name such that the prominence of the trade name adversely affects the prominence of the proper name (610.62(b)). The trade name should be placed in direct conjunction with the proper name, without extra spacing or intervening matter. http://www.fda.gov/downloads/Drugs/
- Remove “Adolescent/Adult” from all sections of each label
4) Single dose syringe: a) Change “0.5 mL” to “One 0.5 mL Dose”; b) Add “Rx Only”;
c) see comment #1 above.
5) Single dose vial: a) Add “Rx Only”; b) See comment #2 above; c) See comment # 3 above.
6) 1 x 0.5 mL prefilled syringe: a) See comment #2 above; b) Orange triangle: See comment #3 above; Note: GSK was advised that they could replace the current wording with “For 10-25 years of age”; c) Dosage section: i) See comment # 3 above, ii) Remove “schedule”.
7) 5 x 0.5 mL prefilled syringes: a) See comment #1 above; b) See comment #2 above; c) Dosage section: i) See comment # 3 above, ii) Remove “schedule”
8) 10 x 0.5 mL single dose vials: a) See comment #2 above; b) Remove: “Preservative Free”
c) Orange triangle: i) Remove “HPV”, ii) See comment #3 above; d) Dosage section:
i) See comment # 3 above, ii) Remove “schedule”.
In response to CBER’s comments, GSK sent revised labels, via email, to CBER on September 28, 2009. GSK made all revisions, as proposed by CBER, with the exception of including “Rx only” on the two container labels. As per 21 CFR 610.60(c), a container capable of bearing only a partial label can be placed in a package which bears all the items required for a package label. CBER reviewed the September 28, 2009, submission and found all revisions and labels acceptable.
Upon review of the submitted container and packaging labels, I recommend approval of these labeling components to support licensure.